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A Toxicological Risk Assessment (TRA) is a safety evaluation of a product based on its composition and intended and probable usage.  The relationship between a hazard and the potential for exposure defines “risk.”  A TRA represents a series of tests or services done to determine the potential risks from exposure to hazardous materials and substances.    

TRAs are performed on specific products, substances, and ingredients to determine whether these components and products will cause any adverse effects on consumer health (both acute and chronic) – such as skin irritation, respiratory problems, eye irritation, allergic reactions, overall sensitivities, organ damage, cancers, etc.  Once all product substances have been analyzed for their inherent toxicity, a TRA should consider the product’s physical characteristics and a handler’s or user’s vulnerability to exposure (through either intended or probable use).

There are essentially 4 steps to a TRA:

  1. Hazard Identification – determining the potential health effects of exposure

  2. Hazard Characterization – determining the potency level of a chemical or ingredient

  3. Exposure Assessment – identifying how much of the substance (chemical or ingredient) may end up in the body due to duration and exposure level

  4. Risk Characterization – a combination of the previous steps in identifying the severity of risk is exposure to a substance


Product safety is one of the biggest concerns that manufacturers have for their products.  Toxicology experts perform TRAs to ensure the safety of the finished product and its ingredients – testing for both synthetic and natural substances and evaluating their safety.  Additionally, ingredients are tested to determine whether they will produce any adverse effects when combined with other ingredients.

Keep in mind that TRAs are not just performed on chemicals and ingredients. TRAs are also conducted on medical devices, biopharmaceuticals, additives, colorants, toys, etc.  Not only are TRAs used to assess product safety for its intended use, but scientists and toxicologists also use TRAs to determine the potential for misuse of the product or ingredient.  This assessment is used to recommend any warning labels that a product should have.  Whether a product is being properly used or misused, it is the manufacturer’s responsibility to market products that do not pose health risks for anyone who comes in contact with them.


If you need a service laboratory – led by highly skilled scientists and toxicologists – to perform your Toxicological Risk Assessment testing and evaluations, reach out to the industry experts by calling ELLIPSE ANALYTICS at 720-340-2297.    

Toxicological Risk Assessment (TRA)

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